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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sampler, Amniotic Fluid (Amniocentesis Tray)
510(k) Number K921738
Device Name SONO-VU US(TM), MODIFICATION
Applicant
E-Z-Em, Inc.
P.O. Box 993
266 Queensbury Ave.
Glens Falls,  NY  12801
Applicant Contact MARLENE WRIGHT
Correspondent
E-Z-Em, Inc.
P.O. Box 993
266 Queensbury Ave.
Glens Falls,  NY  12801
Correspondent Contact MARLENE WRIGHT
Regulation Number884.1550
Classification Product Code
HIO  
Date Received01/29/1992
Decision Date 04/27/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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